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RECRUITING
NCT06042569
PHASE2

Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide works in treating older women with early stage (stage I-III) HER2 negative breast cancer vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are commonly used, but is not well tolerated at the standard dose and can affect the way older patients feel physically and emotionally. Giving dose-reduced docetaxel combined with cyclophosphamide may be an effective treatment option and improve quality of life in vulnerable older women with stage I-III HER2 negative breast cancer.

Official title: Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

174

Start Date

2024-09-16

Completion Date

2030-03-20

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Docetaxel

Given IV

OTHER

Medical Chart Review

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (2)

City of Hope Medical Center

Duarte, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States